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NCT03165526 · ClinicalTrials.gov registry record
The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study
A clinical trial, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- 131
- Enrollment target
NCT03165526: Completed study, sponsored by Abbott Medical Devices.
NCT03165526 is a clinical trial that has completed, run by Abbott Medical Devices. The registered enrollment target is 131 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03165526 has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- 131 participants
- Enrollment target
Study Summary
FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD Occluder (H070005) on January 10, 2017. The Conditions of Approval require that SJM conduct a post approval study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD Occluder.
Primary Outcome
Technical success occurs when a subject is successfully implanted with a PIVSD device in the ventricular septal defect. An implant attempt occurs when the delivery system is inserted in the subject's vasculature.
Interventions
- DEVICE AMPLATZER™ Post-infarct Muscular VSD Occluder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2021-11-29 |
What the finished NCT03165526 record still lists
NCT03165526 is an observational study that tracks outcomes without assigning an intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which AMPLATZER™ Post-infarct Muscular VSD Occluder is the first listed.
NCT03165526 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03165526 about?
NCT03165526 is a clinical study titled "The AMPLATZER™ Post-infarct Muscular VSD Occluder Humanitarian Device Exemption (H070005) Post Approval Study". FDA issued a Humanitarian Device Exemption (HDE) approval order for the AMPLATZER™ PIVSD Occluder (H070005) on January 10, 2017. The Conditions of Approval require that SJM conduct a post approval study to evaluate the safety and probable benefit of the AMPLATZER™ PIVSD Occluder.
What is the current status of trial NCT03165526?
This trial is currently completed. The enrollment target is 131 participants. The study started on 2018-10-01. Estimated completion is 2021-11-29.
What interventions are being tested in trial NCT03165526?
The interventions under investigation include: AMPLATZER™ Post-infarct Muscular VSD Occluder (DEVICE).
Who is sponsoring clinical trial NCT03165526?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
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